Diabetic and neuropathic foot ulcerations can be challenging wounds to heal. The etiology of these ulcerations can vary from compromised blood flow to arthritis, and other conditions and co-morbidities. Total contact casts have been utilized for decades for the treatment of diabetic, neuropathic foot ulcerations, as well as charcot foot deformities.
Total Contact Casting was introduced to the United States nearly 70 years ago from the leper colonies of India and was adopted by our clinicians for the treatment of neuropathic and diabetic foot ulcerations. The total contact cast configuration and application protocol has remained almost exactly the same since the introduction with the exception of new lighter weight materials. This approach to total contact casting is the first new cast configuration that is truly unique from all other systems and has proven to be clinically effective.
Total Contact Casting as described in the name is meant to have as close to intimate contact with the patients leg as possible. This intimate contact is designed to secure the foot and leg in a position that allows for the patient to ambulate while removing the pressure and propulsive forces from the wound and not allowing the foot to move in the cast. The total contact cast should be applied weekly with the exception of the first week at which the cast should be re-applied during the first 48 to 72 hours to accommodate the reduction of swelling and edema in the leg.
A typical total contact cast is applied in several layers. These layers are comprised of a stockinette, a felt pad covering the length of the tibia, a pad covering the lateral and medial maleolous, a layer of rigid plaster, one to two layers of cast padding, a layer of fiberglass, a posterior splint that is fabricated out of a roll of fiberglass tape, unfurled and folded to be three to four layers thick when applied, a rigid walker plate, a rubber walker heel, and a final roll of fiberglass that the clinician will continue rubbing until the cast sets up, approximately ten to twelve minutes post application.
Even the casting system identified in U.S. Pat. No. 6,974,431 is the same as the original total contact cast configuration except in a kit form. There are inherent flaws that all of these accepted existing total contact casting systems have in common that have not been addressed.
Currently less than 2% of clinicians utilize total contact casting to treat their diabetic and neuropathic foot ulcer patients. Past objections to total contact casting were the time it takes to apply, the cost of materials, consistency of application, weight of a cast, and patients developing back and hip pains due to the change in the length of the leg which greatly effects the body mechanics of these already compromised patients.
In addition to the diabetic and neuropathic ulceration application, this versatile system can be utilized as a serial casting system for improving the range of motion for burn, cerebral palsy, spinal bifida, spinal cord injury, muscular dystrophy, idiopathic toe walking, and peripheral neuropathy patients. Applied weekly, gradually increasing the range of motion to a specific limb. This is a non-surgical approach aimed at reducing muscle tightness around the joint that is limiting the range of motion and functional mobility.
Other solutions in existence have merely tried to address the time of application and consistency issues without getting to the core of the problem. Jensen and Gillin developed a cast kit that incorporated all of the components that the clinician would typically assemble separately into one box. The components in the Jensen and Gillin system are essentially the same as any clinician would pull from their inventory with the exception of a unique felt pad that takes what would be two individual pads, the tibial crest and the maleoli pad and connected them as a one piece system. (U.S. Pat. No. 6,974,431)
There is an existing system that resembles a fiberglass sock. This system is not rigid, does not provide intimate contact to the leg, and has to be placed in a removable walker boot to support the system.
Other casting systems discovered during the patent search were designed for stabilizing fractured bones and not for the treatment of a specific condition such as diabetic and neuropathic foot ulcerations.
Currently serial casting consists of specific products that are assembled by a technician to accommodate the defect. This system is geared towards providing all of the components to accommodate a wide range of indications. Additionally this system is universal and will accommodate children to adults.
Conventional total contact casting systems tend to be time consuming, extend the length of limb, can create additional ulcerations, and are difficult to remove.
The Jensen and Gillin system follows the traditional total contact cast configuration with exception to the felt pad that they utilize over the tibia of the leg. Historically there was a separate pad that runs distally from just under the fibular head down to the dorsal aspect of the foot. Additionally there were two felt pads that covered the maleolous to protect them during removal. The pads are taped onto the stockinette while preparing for the cast. Jensen and Gillin connected the maleoli pads creating a one piece system. The Jensen/Gillin system is very time consuming and in most cases requires two clinicians to apply. Once the final roll of cast tape is utilized a clinician has to continue rubbing the fiberglass so that it doesn't un-roll while setting up. This requires approximately 20 minutes to apply and cure.
Another key factor that has effected the popularity of casting are complaints by the patients of hip and back pain. These systems are being utilized for five to eight weeks so the patient is in the cast for quite some time. Existing total contact casting systems utilize several rolls of padding, plaster, and fiberglass to build up the body of the cast. Prior to the application of the rubber walker heel and the last roll of fiberglass a thick rigid plate is placed on the plantar surface of the foot extending from the heel to just under the toes. This plate adds a significant amount of length to the cast as it is not just the thickness of the plate but the fact that it is being balanced at the heel and solace of the foot which are the high points of the plantar foot surface. The plate is utilized to help re-distribute the weight of the patient evenly over the entire foot. Subsequently the plate increases the length of the leg making it disproportionately longer than the other leg thus throwing off the natural body mechanics and causing hip and back pain. Prior systems tend to use traditional components that are very heavy which just exacerbate these conditions for the patient. The Jensen/Gillin system incorporates the heavy materials and a very thick walker plate which doesn't address the issues that have been associated with total contact casting for decades.
Total Contact Casting is meant to have very close contact with the patients limb. This is important in order to assure maximum pressure offloading to the ulcer and minimize movement in the cast. Prior systems utilize cast padding as the first layer covering the stockinette and felt tibial crest pad. This padding breaks down and compresses creating space within the cast. Subsequently, the foot pistons forward and backwards in the cast creating additional ulcerations and pressure points.
Contact Cast removal has been a long standing issue and in several cases where patients have ended up with serious injuries as a result. Prior total contact casting systems are cut down the center of the tibia, over the tibial crest pad, along the dorsum of the foot, over the toes, and then wedges are cut over the maleoli pads. The cast has to spread at the center while supporting the leg with opposing pressure until the cast breaks. This requires a lot of strength and can be very time consuming. Occasionally patients have excessive swelling and end up at the emergency room for removal. A traditional below the knee cast cuts on the lateral and medial sides of the leg with the center removing so the cast literally falls off of the leg. There have been numerous situations where patients have gone to emergency and since the typical doctor is not familiar with the total contact cast removal have cut into and burned the patients legs. None of the prior systems have addressed this chronic struggle up to this time.
There are no known existing serial casting systems commercially available for clinicians to utilize.
It is therefore an object of the invention to provide a turn key, user friendly casting system.
It is another object of the invention to provide a versatile casting system that promotes consistency of application.
It is another object of the invention to provide a casting system that can be utilized for a variety of defects and conditions.
It is another object of the invention to provide a casting system that produces re-producible clinical outcomes.